§ Mr. DalyellTo ask the Secretary of State for Health what analysis his Department has undertaken of the risks of passing Creutzfeldt-Jakob Disease to recipients of a smallpox vaccine made from bovine cell culture. [44007]
§ Ms Blears[holding answer 26 March 2002]: We are not aware that the manufacture of any smallpox vaccine prepared in the past utilised virus culture in bovine cell lines.
If a manufacturer wished to produce smallpox vaccine using virus culture in bovine cells, the appropriate regulatory guidance on cell characterisation and storage would have to be followed.
European legislation demands that an application for marketing authorisation of a medicinal product in the European Union must include satisfactory demonstration of compliance with the European note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.